The FCTS Sterility Test Isolators have been designed for pharmaceutical samples taken from manufactured drug batches and meet all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.
The FCTS Isolators are equipped with the built-in FHPV- Fedegari Hydrogen Peroxide vaporizer, totally engineered and manufactured in-house by Fedegari. With control loop (PID based), the FHPV provides superior reliability and repeatability for easier validation.
- Fixed concentration profile
- Gloves and leak testing totally managed by Thema4
- Significantly reduced operational costs with non-proprietary consumables
- Purpose-built components
- Silicon self-retractable gaskets for 100% air tightness
Contact us for more information or call us on +44 (0)1293 824 400